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Beating the clock

Experts in prostate cancer surgery, Bal Carter and Ted Schaeffer (foreground) are upfront with low-risk patients about the potential for “active surveillance.”

Across the United States, too many men—especially those over 70—are needlessly undergoing prostate cancer surgery, say experts at Hopkins, where a new study offers dramatic evidence that sometimes no treatment is the best treatment.

By Ramsey Flynn

Photos by Mike Ciesielski

Johns Hopkins’Ted Schaeffer is becoming one of the most sought-after prostate surgeons in the world, but even he’s impressed with the emerging disconnect. Frequently in recent years, men newly diagnosed with this second-most common cause of male cancer death will make extraordinary efforts to see him or one of his more than 20 surgical colleagues here. Some even make cross-country pilgrimages. Some come from overseas. Most surprising to him, says Schaeffer, are the anxious patients who won’t take no for an answer.

He recalls the case of one patient who made a cross-country trek, convinced that his cancerous gland needed to come out as quickly as possible. Schaeffer and his associates did the entire work-up, thoroughly reviewing the patient’s scans and pathology reports—scoring the tumor’s degree of aggression as a modest 6 on a 10-scale—and decided this man’s cancer might be better left in than taken out.

“This may surprise you,” Schaeffer told his patient. “We’re very good here at removing cancerous prostates, but I think you might want to consider another option.”

Schaeffer carefully explained that the patient’s cancer grade and volume were low, and that the latest research showed most of these prostate cancers will stay that way without an ambitious intervention. The man was in his 70s and more likely to die of some other affliction than prostate cancer. Schaeffer explained that the patient was a qualified candidate for Hopkins’ “active surveillance” program, which had successfully and quietly presided over the care of hundreds of prostate cancer patients for 16 years. Like the other enrolled patients, this man could undergo annual biopsies, Schaeffer explained, and take action only if Hopkins’ deep bench of prostate experts all agreed that the tumor was stepping out of line.

The idea of sparing a man from such an unpleasant procedure—indeed, one that has posed historical threats of impotence and incontinence—might seem like obvious good news. But Schaeffer and his surgical colleagues had increasingly grown accustomed to how some patients react.

At 38, Schaeffer has a well-established penchant among his surgical colleagues for tackling the high-risk prostate cancers that few other surgeons will take on. He has taken out more than 600 prostate glands—Hopkins surgeons annually remove nearly 1,300 prostates, hundreds more than at any other hospital—leaving behind clear margins in 98 percent of his cases while preserving a man’s sexual and urinary functions. Like many surgeons, Schaeffer really likes doing the procedures. He likes solving the most difficult cases, and prides himself on his department’s ethos for personalized patient service. “If you get surgery from me,” he says plainly, “you get access to my cell phone for life.”

But if there’s one thing that Schaeffer and all of his colleagues hate, it’s the idea of subjecting an acutely worried patient population to unnecessary procedures. His conviction that too many prostates are being removed is increasingly shared by colleagues here, and by a growing number of urologists across the United States.

And yet the disconnect persists.

As of 2008, about 88,000 men in the U.S. had prostatectomies. Of those, more than a third, or 30,000, were performed in men over 65, where benefit is not likely. If urologists separated out the men with low-risk disease and shifted them over to an active surveillance program, prostatectomies would decline by 15,000 cases next year—and the patients, say Hopkins experts and many others, would all be better off.

Active surveillance isn’t altogether new. The basic idea behind it arose in the ’90s. Under the leadership of Patrick Walsh and Alan Partin, it has become quickly and quietly adopted here at Hopkins amid the series of judgment calls that govern when a misbehaving prostate needs to come out. It’s well known that people can live with certain cancers for many years without resorting to surgery. The tumors either grow too slowly to matter during a natural lifetime or a patient can keep the cancer to a mere nuisance-level with advancing noninvasive therapies.

It turns out that prostate cancer is especially well suited to this approach. Though urologists are not yet completely satisfied with the protocols for detecting the risk of prostate cancer through a digital rectal exam and then a series of PSA tests to determine if the level of prostate-specific antigen indicates the need for a biopsy, they place a high level of confidence in the actual biopsy results themselves. By taking between six and 12 core samples of a man’s prostate, doctors can learn how many of the samples show cancer, and then even learn how aggressive that cancer is. A combination of these factors provides a man’s Gleason score based on a 10-scale, with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.

In the coming years, Hopkins researchers believe they will also be able to build aggression-sensitive profiles of prostate cancer cells at a molecular level, which would further add to the protocols for active surveillance.

To researchers watching the trends, it’s becoming increasingly clear that most men diagnosed with prostate cancer have low-risk tumors—tumors that pose little threat to a man’s broader health and longevity. Yet for a variety of reasons, says Hopkins prostate researcher Bal Carter, the active surveillance approach for prostate cancers has been slow to catch on beyond Hopkins.

Carter hopes that will soon change. He recently presided over the release of figures that make it harder for medicine to ignore the truth much longer. In a study published this spring in the Journal of Clinical Oncology, Carter and six colleagues here tallied the results of 769 prostate cancer patients deemed eligible for Hopkins’ active surveillance program going back to 1995, who followed through with the study. All of the patients had low-risk tumors, based on traditional PSA levels and Gleason tumor-grading scores no higher than 6. Most of the study patients were 65 or older, typical of the national picture. In every case, the study rules called for annual biopsies. Any biopsies that showed a significant upgrade in the cancer risk would prompt radiation and/or surgery.

The results? By seven years, only about 50 percent of the men had been treated through surgery or radiation—most triggered by worrisome biopsies. This means that the rest—some 385 patients—got a pass on one of life’s most unpleasant procedures. Furthermore, not a single patient enrolled in Hopkins’ active surveillance program died of prostate cancer.

The bottom line, says Carter, is that Hopkins is making strides by not operating on many cases previously deemed worthy of surgery, especially with older patients. Carter thinks the age range of 65–70 is emerging as one of the key lines of demarcation. “We’re operating on an extremely low percentage of people over the age of 70 who would meet the criteria for favorable risk cancer,” he says, referring to those categorized as having low or very low risk.

“If you want to compare that to the United States, you will probably fall off your chair when I say this. In this institution, of those men over age 70 who are diagnosed with low-risk disease and should be considering surveillance, we’re only intervening with surgery in about 1 percent of those people. Nationally,” he says, “80 percent of these men are undergoing surgery or radiation. And surgical treatment for these men has increased dramatically with the advent of robotic surgery.”

In terms of age-related risk, prostate cancer is very rare in men under 40, and its prevalence is more typical in men over 60. By 75, two in three men have prostate cancer, a fact divined by autopsies of men who died from other causes.

In Carter’s view—echoed by a number of Hopkins colleagues and other leaders in the field across the United States—one of the biggest contributors to prostate cancer’s overtreatment stems from the rise of minimally invasive procedures. While Carter believes as much as any surgeon that these approaches are gaining traction on the merits, he also believes their popularity across the country is oversold in a way that encourages both doctors and patients to opt for taking out low-grade cancerous prostates unnecessarily. With all too many patients, Carter says, the minimally invasive procedures “are not even thought of as an operation.”

For too long, says Carter, the dominant view in prostate care has been that “everyone who gets diagnosed gets treated in a one-size-fits-all approach, regardless of their age, and regardless of the characteristics of their tumor.”

The good news for Hopkins, Carter adds, is that the more conservative active surveillance approach is ascending. “We were very far ahead of the curve on this,” he says. “I think it’s something that Hopkins should be very proud of.”

After Pennsylvania businessman Alex Cameron was diagnosed with prostate cancer in his late 50s, he quietly began downshifting his life plan away from business to something more in line with the church work he’d longed for. In the meantime, Cameron was happy to avail himself of all the best care available in the Philadelphia region, hoping to work with oral medicines to slow down the growth of his cancer as long as possible. But with a wife, three daughters, and eight grandchildren to live for, the simple fact that prostate cancer had its hooks into him weighed on Cameron’s mind. Loved ones and physicians seemed to agree that cancer never sleeps. Why leave a cancerous prostate in when surgeons had become so good at getting them out, especially with such high success rates for preserving nerves and bladder control?

Cameron began exploring his options. He considered the time-honored idea of “seeding” the tumorous gland with small beads containing radiation. He could get the same oncologist who’d seeded Mario Cuomo’s prostate. Or he could use a new external beam technology, which would harness MRI guidance to home in on the actual tumorous lesions within the gland. But both of these approaches were just advance maneuvers that likely assumed the surgery was still coming, and they came with their own troublesome side effects. Cameron also became broadly aware of Hopkins’ active surveillance approach, and wanted to hear what it was all about.

First, Hopkins’ Bal Carter, an accomplished prostate surgeon in his own right, confirmed the bad news. “You do have prostate cancer,” Carter said. “But your Gleason score is low and it’s very slow-growing.” Carter told Cameron he was a good candidate for active surveillance, but Carter didn’t want to overevangelize. “You may want to read up on this.”

Cameron loved the idea of not having his prostate gland removed. Even in the best conditions—open, laparoscopic, or robotically assisted—it’s a major procedure with all of the attendant risks. If the delicate nerve-sparing aspect of the mission didn’t quite go as planned, Cameron had little appetite for exploring the world of erectile dysfunction, or for wearing adult diapers. So what if his gland was more the size of a peach than a walnut? It did the job, and he found the prescribed alpha-blocking agents helpful in keeping the prostate from disrupting urinary function. To him, active surveillance sounded like “a win-win good thing.”

In 1999, Cameron became one of the hundreds of men to enroll in Hopkins’ active surveillance program, placing his faith in the quality of an annual biopsy conducted efficiently on the East Baltimore medical campus, with five of the world’s most precise pathologists ready to examine samples under their microscopes. Cameron says that his biopsies at Hopkins take only minutes, under a local anesthetic. He considers them a minor inconvenience in exchange for his otherwise excellent health.

Since joining the program, Cameron, now 70, has remained very much in life’s saddle, quite literally. When not serving as a minister to the disenfranchised in his area of Pennsylvania near Reading, he likes to take long voyages through New England on his loud Triumph Street Triple motorcycle. “For any guy in my situation,” he says, “active surveillance is the best way to go.”

So if the virtues of active surveillance are so clear, according to the Hopkins study, and if other major academic medical centers are reporting similar results—most notably at the University of Toronto and University of California, San Francisco—why are prostates continuing to come out at a record pace? A quick survey of senior urologists at top academic medical centers blames a host of obstacles, including the current pressures that beset for-profit private hospitals to boost the volume of procedures in a bid to hold onto annual profit margins.

New UCLA urology chief Mark Litwin estimates that just a small fraction, maybe 10 percent, of men with prostate cancer are facing the uncommonly aggressive tumors, and that’s where the focus should be. “The challenge, as I see it,” he says, “is that we still have to get better at learning which of these tumors are tigers and which are just pussycats.”

Tulane’s Oliver Sartor, a professor of oncology and medicine, thinks the time is up for ignoring the confluence of new evidence that prostate cancer is getting overtreated. He talks about findings that he and his own colleagues presented at a recent national gathering of urologists showing that, for patients who had their prostates removed with a PSA of less than 10, survivors were deemed to have gained no benefit from the procedure. “Reducing these surgeries has gained a wider and wider acceptance,” Sartor says. “Sometimes, in medicine, there has to be a tipping point. I feel the tipping point has arrived.”

Other leaders in the field echo these sentiments, sharing genuine consensus that the next grail for enhancing active surveillance is to further refine the protocols for separating out the low-risk and high-risk patients more prospectively. Schaeffer and Carter and dozens of their Hopkins colleagues are all on the case in their lab and research work, currently tapping the prostate tissues from 11 large bio-repositories in a search for more definitive molecular signatures that will help physicians get the drop on prostate cancer’s bad actors.

Prostate cancer has seen more than its share of both overtreatment and undertreatment, says Carter, “but what’s going on in the lab can help solve both of those problems.”

For active surveillance poster boy Alex Cameron, the shift against surgery has already been a boon. He’s inbound for his next biopsy in November. “It’s not really even something I dread,” he says. “It’s just like getting a tooth pulled.”

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The Place to Turn When Surgery’s Needed

While the ascent of active surveillance may be the most game-changing factor in managing prostate cancer today, Johns Hopkins remains the destination of choice for successful prostate removal, especially for high-risk cases.

Though Ted Schaeffer is just one of the 12 most active prostate surgeons here whose reputations help draw patients from all over the world, more than 100 other physicians and researchers with expertise in prostate cancer also add to Hopkins’ clout in the prostate world.

It’s part of what keeps Hopkins ahead of the pack when worried prostate patients get mixed signals after their prostate figures begin setting off alarms. Schaeffer himself recalls one such patient who landed in his custody last September, a British entrepreneur who’d seen 13 experts over the prior months—and gotten 13 different opinions.

Dennis Guise was just 59 then. His overseas physicians had said that, at best, his prostate cancer was so advanced that he needed a radical prostatectomy that would very likely leave him both impotent and incontinent. “How lovely,” Guise responded in the phone call. Soon thereafter, another physician called to inform Guise that the cancer had spread to his lymph nodes. He needed to prepare for surgery.

Instead, Guise crossed the Atlantic, where rising surgeon-researcher Schaeffer and his team assessed him with a PSA level of 6 and a Gleason score of 8. Those were discomforting numbers, said Schaeffer, but he also had another surprise. “I don’t believe the cancer has spread,” said Schaeffer. “Let me ask you this: Have you ever had a prior surgical operation in your pelvis?” Guise confirmed he’d had a hernia repair when he was 10.

Well, said Schaeffer, that would explain the enlarged white echo that previous physicians had spotted on Guise’s CT scans. It was just a 40-year-old surgical scar. “I don’t think your cancer has escaped,” said Schaeffer. “I believe surgery is a good option for you, with a high chance of nerve preservation on that side.”

The March 5 procedure was a complete success. Soon after regaining both his bladder and erectile functions weeks later, Guise formed a new company centered on helping future sufferers of prostate cancer get faster and more reliable prostate data.

Such prowess is the natural product of a urology department that made its first great leaps in prostate care under the aegis of Hugh Hampton Young, who became chair of the Department of Genito-Urinary Diseases of the Dispensary back in 1897. He is credited with performing the first radical perineal prostatectomy in 1904. The department continued to lead the way, later becoming the Brady Urological Institute (named after famed grateful patient James “Diamond Jim” Brady Buchanan in 1912.)

Drawing a steady succession of visionary urologists, “The Brady” (as some here affectionately call it) made some of its most sweeping transformations during Patrick Walsh’s 30-year turn at the helm, which ended in 2004. Walsh is still active with the faculty, and until recently continued to practice the nerve-sparing prostatectomy procedure that he pioneered here at Hopkins. At the end of June, he performed his last prostatectomy—his 4,569th.

Today the group is chaired by Alan Partin, a seasoned international expert in prostatectomy who also has set his sights on the development of new methods for predicting the aggressiveness of prostate cancers. He presides over a department that still rules prostates, performing nearly 1,300 cases a year.

The department’s current leaders are quick to praise the extraordinary skill of the five primary members of the urological pathology group, a unit headed up by Jonathan Epstein, the world’s most-sought figure for second opinions.

The Brady Institute’s gathering of experts has kept it atop its field for 21 straight years in the annual rankings by U.S. News & World Report magazine’s tally of best hospitals.